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OpenTrials
Completed

NCT Number: NCT00684944

Open Label Study of TRx0014 in Alzheimer's Disease

This is an open label, dose-ranging study of two doses of TRx0014 in patients with mild or moderate Alzheimer's Disease. The trial is made available to any patient ongoing on treatment in the clinical trial designated TRx-014-001 at termination of that study. Treatment for each individual patient will continue for as long as the treating physician feels there is benefit to the patient. This current protocol covers each patient for 12 months in the first instance.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient may be of either sex and must be supervised by a carer who is competent to ensure compliance with the medication and who is willing to participate in completing the various assessments. The carer must provide written consent to his or her own participation in the study.
  • Patients with capacity must give written informed consent to participate in this study. Patients who lack capacity to consent must be in agreement with entering into the study and have a personal legal representative giving written informed consent to their participation.
  • The patient must have been ongoing in TRx-014-001 at time of study termination.

Exclusion criteria

  • There are no exclusion criteria. All patients taking medication at the termination of study TRx-014-001 and who wish to participate are eligible for recruitment.

Treatment and study plan

TRx0014

Drug

Gelatin capsule, tid

Primary outcomes

  1. Cognitive ability measured by the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and by the Mini-Mental State Examination (MMSE).

    Time frame: 0, 26 and 52 weeks

Secondary outcomes

  1. Dementia severity assessed by the Clinical Dementia Rating - sum of the boxes (CDR-sb).

    Time frame: 0, 26 and 52 weeks

  2. Daily living activities assessed by the Alzheimer's Disease functional Assessment and Change Scale (ADFACS)

    Time frame: 0, 26 and 52 weeks

Sponsors and collaborators

Lead sponsor

TauRx Therapeutics Ltd

Industry

Registry information

Official study title

An Open Label Continuation Study of the Effects of TRx0014 30 mg TID and 60 mg TID in Patients With Alzheimer's Disease

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 28, 2008
Registry last updated
Apr 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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